- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07644871
A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation
A Multi-Center, Randomized, Blinded, Split-Face, Controlled Clinical Study to Assess Two Targeted Brightening Serum (A and B) Paired With 4% Hydroquinone
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a four-week multi-center, single-blind, randomized, split-face, controlled pilot study conducted to assess the efficacy and tolerance of two pigment correction formulations (Brightening Serum A and Brightening Serum B) compared to 4% Hydroquinone split face when used over the course of 4 weeks by healthy females with clinically determined mild to severe facial hyperpigmentation, including melasma on the global face. Subjects will be randomized into 2 cells which will receive the following split face treatments:
- Cell 1: Brightening Serum A versus 4% Hydroquinone
- Cell 2: Brightening Serum B versus 4% Hydroquinone It was hypothesized that the Brightening Serum A and B will produce statistically significant improvements at post-baseline timepoints when compared with baseline, and comparable improvements versus the standard of care 4% Hydroquinone across the primary endpoint, secondary and tertiary endpoints. Additionally, the Sponsor's test materials will be well tolerated by subjects, with no statistically significant increases in scores for tolerability/safety parameters, specifically erythema and dryness, at any study timepoint when compared with baseline scores. Furthermore, the Sponsor's test materials will be well perceived by subjects according to analyses of self-assessment questionnaires, with a statistically significant proportion of favorable responses compared to unfavorable responses and/or a statistically significant improvement in subject response values when compared with baseline.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Irving, Texas, Estados Unidos, 75063
- Revision Skincare
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type)
- Age 20 to 60 years.
- Subjects with self-perceived hyperpigmented facial skin
- Having mild to severe (score of 3-9 according to a modified Griffiths scale,2 where 0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 9 = severe) full-face hyperpigmentation, including melasma. Hyperpigmentation and melasma must present at equal severity and size on each facial side.
- Willing to maintain visit 1/baseline condition of eyebrows and eyelashes (do not noticeably change brow/lash appearance) during the study.
- Willing to provide written informed consent and able to read, speak, write, and understand English.
- Willing to sign a photography release.
- Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.
Exclusion Criteria:
- Having been diagnosed with known allergies to skin care products.
- Having a known reactivity to tranexamic acid, niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, yeast, ascorbic acid, tetrahexyldecyl ascorbate, and/or any of the ingredients in the study products.
- Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
- Having a history of skin cancer within the past 5 years.
- Currently taking oral or topical prescription medications for melasma such as Triluma, compounded hydroquinone, retinoids, and tranexamic acid.
- Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, bactrim, tetracycline, erythromycin, vibramycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
|
Comparador activo: Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
|
Otro: 4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Measurement of Clinical Efficacy Parameters by Clinical Grader
Periodo de tiempo: Baseline, week 2, week 4
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Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness, hyperpigmentation on the global face, and overall appearance.
Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition.
A decrease in score/ value indicates an improvement.
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Baseline, week 2, week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Measurement of Global Melasma Severity Assessment Score (GMSA)
Periodo de tiempo: baseline and weeks 2 and 4
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The expert grader (Board-Certified Dermatologist) will evaluate the right and left facial side using a Global Melasma Severity Assessment (GMSA) according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition. 0 = clear
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baseline and weeks 2 and 4
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Measurement of facial Melasma
Periodo de tiempo: Baseline, week 2 and week 4
|
The MASI score is a clinical tool used to assess the severity of melasma, a hyperpigmentation disorder, in terms of both area and darkness.
It quantifies the extent and intensity of melasma in four facial regions: the forehead (F), right malar region (MR), left malar region (ML), and chin (C), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively.
A decrease in score indicates improvement
|
Baseline, week 2 and week 4
|
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Incidence of Treatment- Emergent Adverse Events
Periodo de tiempo: Baseline, week 2, and week 4
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Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face.
Objective irritation (clinically graded): erythema, edema, and dryness.
Subjective irritation (assessed by subjects): burning, stinging, and itching.
Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe).
A decrease in value indicates an improvement.
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Baseline, week 2, and week 4
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 07242025
- Revision Skincare, LLC (Otro número de subvención/financiamiento: Revision Skincare, LLC)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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